MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Model Number FEM12040

Device Problems Positioning Failure (1158); Fracture (1260); Material Perforation (2205); Misfire (2532); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the device allegedly failed to deploy.It was further reported that shaft was allegedly bent.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the physical sample for returned for evaluation.Based on the investigation performed in the laboratory, the stent graft was found partially deployed, the outer sheath was found fractured, and two stent struts were found perforating the outer sheath.The perforation of the sheath by two of the struts of the stent is assessed as being the main issue, which led to partial deployment of the stent graft and fracture of the outer sheath.No bent was identified on the shaft of the system.No manufacturing issues were identified.Based on the investigation of the provided information, the investigation is closed as confirmed for perforation of the outer sheath by two struts of the stent graft as the issue, which led to the partial deployment of the stent graft and the fracture of the outer sheath.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding the preparation of the device the instructions for use states 'flush the stent graft lumen with sterile saline by using a small volume syringe.A) attach the syringe to the luer port at the back of the endovascular system (b) attach the syringe to the luer port on the y-adapter, close the stopcock when flushing is complete and remove the syringe from the luer port'.Regarding the precautions prior and during deployment the instructions for use states 'prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure' and 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' the instructions for use states regarding the accessories 'the use of an appropriately sized introducer sheath is recommended; prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location' the packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.Expiry date: 01/2025.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15637148
• MDR Text Key: 302438387
• Report Number: 2020394-2022-00819
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008639
• UDI-Public: (01)04049519008639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM12040
• Device Catalogue Number: FEM12040
• Device Lot Number: ANGN1237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1